PARACEM UNIVERSAL DC

K053040 · Coltene/Whaledent AG · EMA · Nov 9, 2005 · Dental

Device Facts

• Record ID: K053040
• Device Name: PARACEM UNIVERSAL DC
• Applicant: Coltene/Whaledent AG
• Product Code: EMA · Dental
• Decision Date: Nov 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ParaCem Universal DC is indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, veneers and for core build-ups

Device Story

ParaCem Universal DC is a dental cement used by dentists for permanent cementation of indirect restorations (crowns, bridges, inlays, onlays, veneers) and endodontic posts, as well as for core build-up procedures. The device is applied by the clinician to the restoration or tooth surface to provide adhesion and structural support. It functions as a restorative material within the dental clinic setting. The output is a hardened cement layer that secures the dental prosthesis or core material, facilitating long-term restoration stability and patient oral function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cure (DC) dental cement. Chemical composition and physical properties consistent with Class II dental cements (21 CFR 872.3275(b)).

Indications for Use

Indicated for dental patients requiring cementation of endodontic posts, crowns, bridges, inlays, onlays, veneers, or core build-ups. No specific age or gender restrictions noted.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized representation of a human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2005

Coltene/Whaledent AG C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128

Re: K053040

Trade/Device Name: ParaCem Universal DC Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA and KLE Dated: October 24, 2005 Received: October 28, 2005

Dear Mr. Vogelstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

## Page 2 - Mr. Henry J. Vogelstein

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu S. Lin, PhD

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for "coltène whaledent". The logo is in black and white, with the word "coltène" on top and "whaledent" on the bottom. There are two black diagonal lines to the right of the word "coltène". The font is bold and sans-serif.

Coltène/Whaledent AG 510(k) Submission ParaCem Universal DC Indications for use

## Indications for use

510(k) Number (if known): mk

Image /page/2/Picture/4 description: The image shows the text 'KO 53040' in a handwritten style. The characters are bold and slightly distorted, giving them a unique, imperfect appearance. The text is arranged horizontally, with a clear separation between the letters and numbers.

Device Name:

ParaCem Universal DC

Indications for use:

- ParaCem Universal DC is indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, veneers and for core build-ups

× Prescription Use: (21 CFR Part 801 Subpart D) Over-the Counter Use: _ (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

and/or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ringer

ോം Sign-Off) Cision of Anesthesiology, General Hospital, Intection Control, Dental Devices

Number: K053044